BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENRHYTHM MRI

    MDR report key: 2977284 · Received February 25, 2013

    Report

    Report Number
    9614453-2013-00513
    Event Type
    Death
    Date Received
    February 25, 2013
    Date of Event
    September 1, 2009
    Report Date
    January 31, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT, WHO WAS A PARTICIPANT IN THE (B)(4) STUDY, IS DECEASED. THE DEATH OCCURRED FIVE MONTHS POST IMPLANT OF THE DEVICE. THE CAUSE OF DEATH IS UNKNOWN. THE ADVERSE EVENT COMMITTED OF THE STUDY CLASSIFIED THE RELATEDNESS OF THE ADVERSE EVENT TO THE PROCEDURE OR DEVICE AS "UNKNOWN" AND THE DEATH HAS BEEN CLASSIFIED AS "UNKNOWN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80742 ENRHYTHM MRI PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND EMDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Death